Stem cell drugs in the making in India

By Papri Sri Raman Chennai, July 8 (IANS) A stem cell drug common for everybody and yet targeted at specific organ regeneration? Something that can be bought off the shelf like an injection? An Indian research company is in the process of making just that. Stempeutics Research Private Ltd last November applied to the Central Drug Control Administration and the Indian Council of Medical Research for permission to conduct clinical trials for such drugs.

Housed in the Manipal Hospital on Bangalore’s outskirts, and associated with Manipal University, Stempeutics focuses on the therapeutic use of stem cell for treatment of a host of diseases. Among them are heart and brain strokes, blood vessel deterioration, muscle damage, spinal cord injury, bone fracture, diabetes and rheumatoid arthritis.

Stempeutics, which has laboratories in Bangalore and Malaysia, has had two trials of its stem cell drugs, one to stop heart attacks and the second to regenerate an artery in the leg.

“If a drug that can be stocked and delivered can be made of stem cells, it will bring down the cost of therapy dramatically,” B.N. Manohar, the research company’s president, told IANS during a visit to Chennai.

Stem cells can become ‘medicine’ for several diseases, especially neurological ones. While stem cell therapy is patient-specific right now the world over, Stempeutics is attempting drugs that can be common to people.

Washington University scientists have already established that genes can direct embryonic stem cells to become heart cells, proving that stem cells can be remote controlled, and given orders. Such drugs are in stage two and three of clinical trials in the US and Canada.

The Indian researchers at Stempeutics are investigating the properties of adult mesenchymal cells, obtained from the bone marrow.

Cells found between the ectoderm and endoderm layers of the human body are called the middle cells (mesodermal cells) or mesenchymal cells. They have the ability to move and differentiate to become specialised organs. In the brain region, they can become brain parts, neurons and nerves.

Stempeutics researchers say mesenchymal stem cells in adults can be used “to replace damaged and missing cells in adults”.

The autologous procedure is that the stem cell is extracted from individual patients, cultured and multiplied in the lab, in a bio-generation machine known popularly as the “cell factory”.

A 10-cell stack can grow 750 million cells. A regeneration machine can have up to 40-cell stack. One million cells are required for one kilogram body weight.

When large quantities are regenerated outside the patient’s body, injections are made of a specified dose and the regenerated cell is then injected into the body part/area that needs the stem cell to become the missing portion.

A 60-year-old American patient of Pakistani origin, Andrew Kisana from Salt Lake City, has had three such stem cell injections in the last two years from Stempeutics and shown considerable improvement.

There has to be a gap of six months at least between two stem cell injections, and the patient’s progress is closely monitored.

“A Canadian patient brought us a voluntary donor. We reserved some cells for a second dose of injection of stem cells. We realise that mesenchyma cells do not require matching,” Manohar said.

Stempeutics has about a dozen patients in various stages of stem cell therapy. One of them is Prabhaben, in her late 30s, from Ahmedabad who suffered a spinal cord injury when she was thrown from a giant wheel two years ago. She was rendered immobile by the fall. After stem cell therapy, she can now walk with a walker.

Stempeutics also has a 37-year-old French quadriplegic - all her four limbs are paralysed - patient who has been unable to move since she was 12. Now the patient has sought stem cell therapy.

Extracting and culturing stem cells from each individual patient is a time-taking process, as all safety conditions have to be met scrupulously.

India has almost 150,000 Parkinson’s disease victims. They can be provided relief with stem cell therapy, but the numbers make the treatment rare.

Parkinson’s disease is a degenerative disorder of the central nervous system that often impairs the sufferer’s motor skills (mobility) and speech. It is said to be caused by the insufficient generation of a substance called ‘dopamine’ by the brain.

“If stem cells can be ordered to generate those specific neurons in the brain that will produce dopamine and be made into a drug for use by all Parkinson’s patients,” then stem cells will become an easily available therapy for thousands, Manohar said.